82 FR 35140 - Schedule for Rating Disabilities; The Genitourinary Diseases and Conditions

DEPARTMENT OF VETERANS AFFAIRS

Federal Register Volume 82, Issue 144 (July 28, 2017)

Page Range		35140-35148
FR Document		2017-15765

The Department of Veterans Affairs proposes to amend the portion of the Schedule for Rating Disabilities that addresses the genitourinary system. The purpose of this change is to update current medical terminology, incorporate medical advances that have occurred since the last review, and provide well-defined criteria in accordance with actual, standard medical clinical practice. The proposed rule reflects the most up-to-date medical knowledge and clinical practice of nephrology and urology specialties, as well as comments from subject matter experts and the public garnered during a public forum held January 27-28, 2011.

Federal Register, Volume 82 Issue 144 (Friday, July 28, 2017)

[Federal Register Volume 82, Number 144 (Friday, July 28, 2017)]
[Proposed Rules]
[Pages 35140-35148]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-15765]

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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 4

RIN 2900-AP16

Schedule for Rating Disabilities; The Genitourinary Diseases and
Conditions

AGENCY: Department of Veterans Affairs.

ACTION: Proposed rule.

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SUMMARY: The Department of Veterans Affairs proposes to amend the
portion of the Schedule for Rating Disabilities that addresses the
genitourinary system. The purpose of this change is to update current
medical terminology, incorporate medical advances that have occurred
since the last review, and provide well-defined criteria in accordance
with actual, standard medical clinical practice. The proposed rule
reflects the most up-to-date medical knowledge and clinical practice of
nephrology and urology specialties, as well as comments from subject
matter experts and the public garnered during a public forum held
January 27-28, 2011.

DATES: Comments must be received on or before September 26, 2017.

ADDRESSES: Written comments may be submitted through
www.Regulations.gov; by mail or hand-delivery to Director, Regulation
Policy and Management (00REG), Department of Veterans Affairs, 810
Vermont Avenue NW., Room 1068, Washington, DC 20420; or by fax to (202)
273-9026. Comments should indicate that they are submitted in response
to ``RIN 2900-AP16--Schedule for Rating Disabilities; The Genitourinary
Diseases and Conditions.'' Copies of comments received will be
available for public inspection in the Office of Regulation Policy and
Management, Room 1063B, between the hours of 8:00 a.m. and 4:30 p.m.,
Monday through Friday (except holidays). Please call (202) 461-4902 for
an appointment. (This is not a toll-free number.) In addition, during
the comment period, comments may be viewed online through the Federal
Docket Management System at www.Regulations.gov.

FOR FURTHER INFORMATION CONTACT: Ioulia Vvedenskaya, M.D., M.B.A.,
Medical Officer, Part 4 VASRD Regulations Staff (211C), Compensation
Service, Veterans Benefits Administration, Department of Veterans
Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 461-9752.
(This is not a toll-free telephone number.)

SUPPLEMENTARY INFORMATION: As part of the Department of Veterans
Affairs' (VA) ongoing revision of the Schedule for Rating Disabilities
(VASRD), VA proposes changes to the portion of the VASRD that addresses
the genitourinary system, which was last revised in 1994. See 59 FR
2523 (Jan. 18, 1994); see also 59 FR 46338 (Sep. 8, 1994). Through this
revision, VA aims to eliminate ambiguities, include medical conditions
not currently in the rating schedule, implement current, well-refined
medical criteria, and update terminology to reflect the most recent
medical advances.

I. Proposed Changes to Sec. 4.115

Currently, 38 CFR 4.115 (``Nephritis'') does not adequately reflect
current concepts of renal and urinary tract disease and conditions.
Regardless of specific disease pathology, kidney conditions generally
produce the same symptomatology and lead to the same functional
impairment. Therefore, for rating purposes, analysis of pathology, such
as is currently presented in the first three sentences of Sec. 4.115,
is unnecessary and VA proposes to remove this language.
However, VA proposes to retain the remainder of the language in
Sec. 4.115, which addresses the assignment of ratings when both renal
and cardiovascular conditions are present, but replace the reference to
``nephritis'' in the first sentence of the proposed revised section
with ``renal disease'' to more accurately reflect the applicability of
the provision. VA proposes to retitle this provision as ``Co-existence
of Renal and Cardiovascular Conditions'' to better address the amended
content.

II. Proposed Changes to Sec. 4.115a

Under the current VASRD, diseases of the genitourinary system are
listed at 38 CFR 4.115b with instructions directing rating personnel to
various rating criteria found at 38 CFR 4.115a, when appropriate. The
rating criteria in Sec. 4.115a address impairment of the genitourinary
system, including renal dysfunction, voiding dysfunction, and
infections.
The introductory paragraph in Sec. 4.115a states that when the
VASRD refers a decision maker to these areas of dysfunction, only the
predominant area of disability will be considered for rating purposes.
VA proposes clarifying this statement by noting that distinct
disabilities may be assigned separate evaluations under this section,
pursuant to the pyramiding provisions in Sec. 4.14. This statement is
intended to reflect that when a particular diagnostic code refers to
multiple dysfunctions, only the

[[Page 35141]]

predominant dysfunction will be evaluated for that diagnostic code.
Distinct disabilities resulting in non-overlapping symptoms may be
assigned separate evaluations, however.
VA also proposes to make changes to the rating criteria found in
Sec. 4.115a; these proposed changes are discussed below.

A. Renal Dysfunction

Currently, VA evaluates renal dysfunction as follows:
A 100 percent evaluation is assigned for any of the following:
Requiring regular dialysis, or precluding more than sedentary activity
from one of the following: Persistent edema and albuminuria; or, BUN
more than 80 mg%; or, creatinine more than 8 mg%; or, markedly
decreased function of kidney or other organ systems, especially
cardiovascular.
An 80 percent evaluation is assigned for any of the following:
Persistent edema and albuminuria with BUN 40 to 80 mg%; or, creatinine
4 to 8 mg%; or, generalized poor health characterized by lethargy,
weakness, anorexia, weight loss, or limitation of exertion.
A 60 percent evaluation is assigned for any of the following:
Constant albuminuria with some edema; or, definite decrease in kidney
function; or, hypertension at least 40 percent disabling under
diagnostic code 7101.
A 30 percent evaluation is assigned for any of the following:
Albumin constant or recurring with hyaline and granular casts or red
blood cells; or, transient or slight edema or hypertension at least 10
percent disabling under diagnostic code 7101.
A 0 percent evaluation is assigned for either albumin and casts
with a history of acute nephritis; or, hypertension non-compensable
under diagnostic code 7101.
Subjective terms such as ``markedly,'' ``some,'' and ``slight''
contribute to inconsistent evaluation of genitourinary disabilities
rated under this criteria. Therefore, VA proposes to replace these
subjective criteria with specific objective laboratory findings, such
as the glomerular filtration rate (GFR). Modern medicine states the
``[GFR] is widely accepted as the best overall measure of kidney
function in health and disease.'' Nat'l Kidney Found., ``K/DOQI
Clinical Practice Guidelines for Chronic Kidney Disease: Evaluation,
Classification, and Stratification,'' Am. J. Kidney Disease 39:S1-S266,
S5 (2002), available at https://www.kidney.org/sites/default/files/docs/ckd_evaluation_classification_stratification.pdf (last viewed Oct.
7, 2016). In clinical practice, subject matter experts have noted an
inverse correlation between GFR and functional impairment (e.g., lower
GFRs correspond to greater impairment), and individuals with GFRs less
than 60 mL/min are considered to have chronic renal disease. Id. at
S12. A GFR less than 60 mL/min is also a sign of renal failure. Id. In
addition to using the GFR for evaluation purposes, VA also proposes
adding a note to the evaluation criteria specifying that GFR, estimated
GFR (eGFR), and creatinine based approximations are acceptable for
evaluation purposes, as each has been shown to be an adequate indicator
of the stage of chronic kidney disease. Id. at S81. The GFR used must
be medically appropriate and calculated by a medical professional.
Based on the level of kidney function generally associated with a
particular GFR, VA proposes assigning a 100 percent evaluation for a
GFR less than 16 mL/min; an 80 percent evaluation for a GFR between 16
and 29 mL/min; a 60 percent evaluation for a GFR between 30 and 59 mL/
min; a 30 percent evaluation for a GFR greater than or equal to 60 mL/
min with at least one of the following: Albumin/creatinine ratio (ACR)
greater than or equal to 2.5 g/gm (nephrotic range proteinuria), or
hypertension at least 10 percent disabling under diagnostic code 7101;
and a 0 percent evaluation for a GFR greater than or equal to 60 mL/min
with at least one of the following: ACR greater than or equal to .03 g/
gm but less than or equal to 2.49 g/gm, or hypertension that is non-
compensable under diagnostic code 7101. These levels of evaluation
correlate to a modified staging classification of chronic kidney
disease by the National Kidney Foundation. Id. At the 100 percent
evaluation, the designated GFR is associated with kidney failure and,
at the 0 percent evaluation, the designated GFR is associated with an
increased risk of kidney damage where a diagnosis of chronic kidney
disease has been made. Id. Intermediate levels of evaluation at the 30,
60, and 80 percent levels correspond to the remaining stages of chronic
kidney disease as they increase in severity as manifest by declining
GFR or increasing proteinuria.
Proteinuria is considered in the evaluation of chronic kidney
disease at the 30 and 0 percent levels because GFR measures only the
ability of the kidneys to filter the blood and does not always provide
a complete picture of renal disease. For example, in the early stages
of chronic renal disease resulting from kidney damage, GFR may be
within the normal range and impairment may be characterized by other
diagnostic abnormalities, such as increased secretion of protein in the
urine (proteinuria). Id. at S71. Proteinuria, as measured by increased
urinary excretion of albumin, is an early and sensitive marker of
kidney damage in many types of chronic kidney disease. Id. at S48,
S101. Therefore, VA proposes that an ACR of 2.5 g/gm or greater (also
called nephrotic range proteinuria) would warrant a 30 percent
evaluation and an ACR of at least 0.03 g/gm but no more than 2.49 g/
gm--i.e., urinary albumin that does not reach the level of nephrotic
range proteinuria--would warrant a 0 percent evaluation. VA would not
eliminate reference to hypertension in the 0 and 30 percent evaluation
criteria because sustained elevation of arterial blood pressure may be
a consequence of chronic kidney disease. Id. at S125-26.
Finally, a 100 percent evaluation would still be assigned for
chronic kidney disease requiring regular, routine dialysis. VA intends
to also extend this evaluation to individuals requiring a kidney
transplant who may not yet require regular, routine dialysis. Often, a
patient with rapidly deteriorating chronic kidney disease will be
placed on a transplant list before they require regular, routine
dialysis, although dialysis may actually be required before the
transplant is performed.

B. Urinary Tract Infection

VA proposes to preserve the existing rating criteria for urinary
tract infection with little change. VA does, however, propose to
clarify the criteria for a 30 percent evaluation by specifying that
drainage would be by stent or nephrostomy tube. This differentiates
drainage via catheterization. Stent or nephrostomy tube insertion are
surgical procedures and require more intensive medical management than
drainage via catheterization. Catheterization is not medically
consistent with the remainder of the criteria required for a 30 percent
evaluation because the need for catheterization is not generally
accompanied by frequent hospitalization (greater than two times/year)
or continuous intensive management.
For the 10 percent evaluation, VA proposes to replace the ambiguous
phrase ``intermittent intensive management'' with ``suppressive drug
therapy lasting six months or longer.'' Antibiotic and suppressive
medications are typically the treatment used to treat urinary tract
infections. Charles Kodner et al., ``Recurrent Urinary Tract Infections
in Women: Diagnosis and Management,'' 82(6) Am. Family Physician 638-43
(2010); B. Lee et al.,

[[Page 35142]]

``Methenamine hippurate for preventing urinary tract infections,'' The
Cochrane Library (Oct. 17, 2012), http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD003265.pub3/abstract (last visited April 16, 2014).
However, the term ``intensive management'' suggests something beyond
short-term courses of antibiotic treatment for urinary tract
infections; this is not clear from the current definition. As such, VA
intends to replace ``intensive management'' with the objective
criterion of ``suppressive drug therapy lasting six months or longer.''
As for the length of time selected, suppressive therapy is more
appropriate for a chronic infection. B. Lee, supra. Recurrent, or
chronic, infections are generally defined as two or more infections in
six months, and the recommended treatment is six to twelve months of
suppressive drug therapy. Kodner, supra. Therefore, VA proposes a 10
percent evaluation when there are one to two hospitalizations per year
for urinary tract infections, or suppressive drug therapy lasting six
months or longer is required.
The addition of a 0 percent evaluation is also proposed and would
be applicable if a veteran has urinary tract infections that require
suppressive drug therapy for less than 6 months. Under this evaluation,
drug suppressive therapy lasting six months or longer is not required.
This proposed evaluation would cover cases that are responsive to
treatment and/or are not severe enough to require suppressive drug
therapy for six months of more. It would also ease field application by
specifying non-compensable criteria that can be compared to the
criteria warranting a compensable evaluation.

III. Proposed Changes to Sec. 4.115b

A. Diagnostic Codes (DCs) 7508 and 7510

VA proposes to amend these DCs based on a better understanding of
the disease process and the impact of treatment. When imbalances occur
in the body, substances in urine can form solid pieces within the
urinary tract. These pieces are commonly referred to as stones.
Nephrolithiasis, to which diagnostic code 7508 currently applies, is
another name for kidney stones. Ureterolithiasis (current DC 7510)
refers to stones in the ureter, which is the tube that carries urine
from the kidney to the bladder.
Regardless of whether the stone is in the kidney or the ureter,
symptoms may include abdominal and/or back pain and blood in the urine.
This shared symptomology leads to similar functional impairment.
Therefore, VA proposes to delete existing DC 7510 and to evaluate
stones in either the kidney or the ureter under diagnostic code 7508.
Nephrocalcinosis, a disorder in which excess calcium accumulates in
the kidneys, does not result in symptoms. Rather, if the accumulation
of calcium leads to the creation of stones, the stones themselves may
cause symptoms. This condition is commonly evaluated under DC 7508 as
analogous to nephrolithiasis, and VA proposes that it continue to be
evaluated under this code, but that it be expressly added to the
diagnostic code for ease of field application. Therefore, to better
express the conditions to be evaluated under DC 7508, VA proposes to
rename it as ``Nephrolithiasis/Ureterolithiasis/Nephrocalcinosis.''
Proposed DC 7508 would provide a 30-percent rating for recurrent
stone formation requiring invasive or non-invasive procedures more than
two times per year, as current DC 7508 does, but would no longer
provide a 30-percent rating for diet or drug therapy, because such
therapies have no specific relationship to these disabilities and are
widely recommended for the majority of medical diseases and conditions.

B. DCs 7520 Through 7522

Current DCs 7520 and 7521 provide compensation for actual physical
removal of the penis or glans. An evaluation of 30 percent is provided
when there is removal of half or more of the penis under DC 7520. In
addition, a 20 percent evaluation is assigned when there is removal of
the glans under DC 7521. Current DCs 7520 and 7521 also permit rating
these conditions alternatively as voiding dysfunction in Sec. 4.115a.
VA proposes to no longer rate these conditions as voiding dysfunction,
which pertains to issues of leakage and frequency and the use of an
appliance or absorbent materials. VA also proposes to revise DCs 7520
and 7521 to include a footnote reference to consider entitlement to
Special Monthly Compensation (SMC) for loss of a creative organ under
Sec. 3.350. This is meant to correct the omission of this note from
previous versions of the VASRD. Removal of half or more of the penis,
or removal of the glans, may result in loss of a creative organ.
Therefore, although consideration of SMC is considered with application
of these diagnostic codes under current policy, this change would
ensure consistent consideration of SMC for loss of a creative organ.
VA proposes to revise DC 7522 to encompass erectile dysfunction
(ED), regardless of etiology. In making this change, VA intends to
retitle this diagnostic code, ``Erectile dysfunction.'' ED can occur
with or without deformity of the penis, and is a symptom of many
systemic, psychological, and metabolic diseases. W. Ludwig, ``Organic
causes of erectile dysfunction in men under 40,'' 92(1) Urologia
Internationalis 1-6 (2014).
VA proposes to no longer provide a 20-percent rating for this
condition, whether with or without penile deformity. VA provides
disability compensation for conditions that result in reduced earning
capacity. 38 U.S.C. 1155. Erectile dysfunction, with or without penile
deformity, is not associated with reductions in earning capacity.
Therefore, VA proposes to provide a 0 percent evaluation for this
condition. Section 4.115b's footnote regarding consideration of SMC for
loss of use a creative organ where warranted would continue to apply to
DC 7522.
VA also proposes to add a note clarifying that Peyronie's disease
is not a ratable condition. Peyronie's disease should not be rated
analogously to ED.

C. DC 7524

VA does not propose any substantive changes to current DC 7524.
However, it does intend to correct a typographical error in the last
sentence of the existing note, which refers to ``underscended'' rather
than ``undescended'' testis.

D. DCs 7525, 7527, 7533, 7534, and 7537

Currently, each of these diagnostic codes identifies one or more
conditions which have similar symptomatology and functional impairment.
The conditions identified are not an exclusive list; therefore, other
conditions are often rated as analogous to one of these diagnostic
codes. To assist the field in ensuring that the appropriate diagnostic
criteria is used to evaluate other conditions not currently listed, VA
proposes to rename each of these diagnostic codes and/or include a note
identifying those conditions not currently listed.
First, VA proposes to rename DC 7525 as ``Prostatitis, urethritis,
epididymitis, orchitis (unilateral or bilateral), chronic only,'' as
these diagnoses all refer to urinary tract infections that do not
involve the kidneys and have similar symptoms. Prostatitis would not be
included in proposed revised DC 7527, ``Prostate gland injuries,
infections, hypertrophy, postoperative residuals, bladder outlet
obstruction,'' because it is rarely caused by a bacterial infection and
generally results in repeated bladder infections. J. Stevermer et al.,
``Treatment of Prostatitis,'' 61(10) Am.

[[Page 35143]]

Family Physician 3015-22 (2000). As a result, the diagnoses contained
in DC 7527 are not consistent with non-bacterial prostatitis. In
addition, the symptoms caused by prostatitis--recurrent bladder
infections--are most similar to the diagnoses contained in DC 7525.
There is no change to the evaluation criteria for this DC.
VA also proposes to rename DC 7527 to include bladder outlet
obstruction, which has the same functional impairment and
symptomatology as the other conditions currently encompassed in this
code. Bladder outlet obstruction is not included in current DC 7517,
``Bladder, injury of,'' because this condition is not caused by an
injury to the bladder, but is generally caused by another condition,
such as benign prostatic hypertrophy (BPH), which is addressed in DC
7527. R. Dmochowski, ``Bladder Outlet Obstruction: Etiology and
Evaluation,'' 7(Supp. 6) Reviews in Urology S3-S13 (2005). In addition,
the symptomatology for this condition may include urinary tract
infections, rather than only voiding dysfunction, as contemplated by DC
7517. There is no change to the evaluation criteria for this DC.
VA proposes to add a note to DC 7533 to identify some of the most
common cystic kidney diseases seen in the veteran population, to
include polycystic disease, uremic medullary cystic disease, medullary
sponge kidney, and similar conditions such as hereditary nephritis,
Alport's syndrome, cystinosis, primary oxalosis, and Fabry's disease.
M. Bisceglia et al., ``Renal cystic diseases: a review,'' 13(1)
Advances in Anatomic Pathology 26-56 (2006). These diseases are being
added as a medical update and would ensure proper field application of
this DC. There is no change to the evaluation criteria for this DC.
Regarding DC 7534, which deals with atherosclerotic renal disease,
VA proposes to specifically identify another atherosclerotic renal
disease--large vessel disease, unspecified. Renal Failure: Diagnosis
and Treatment 65 (J. Gary Abuelo ed. 1995). This disease is being added
as a medical update and would ensure proper field application of this
DC. There is no change to the evaluation criteria.
Finally, VA proposes to amend DC 7537 to identify the most common
forms of interstitial nephritis resulting from the high prevalence of
the disease, including gouty nephropathy and disorders of calcium
metabolism. There is no change to the evaluation criteria.

E. DCs 7539 and 7541

VA proposes to move all conditions contained in DC 7541 to DC 7539,
with the exception of renal involvement in diabetes mellitus, to
encompass all systemic conditions that impact the kidneys. All of these
conditions are, as amyloid diseases, systemic diseases with renal
involvement and therefore are more appropriately evaluated under a
single DC. For clarity and ease of field application, VA proposes to
add a note to DC 7539 to identify all forms of glomerulonephritis,
nephritis, and renal vasculitis encountered with systemic diseases.
There is no change to the evaluation criteria.
As for renal involvement in diabetes mellitus (e.g., diabetic
nephropathy), VA proposes to continue rating this condition separately
under DC 7541. Although this condition would also be rated as renal
dysfunction, VA finds there is a need to track this particular
condition given its incidence and prevalence in the Veteran population,
especially with regard to claims related to Agent Orange exposure.

F. DC 7542

Based on modern clinical findings, neurogenic bladder should
continue to be rated as a voiding dysfunction. However, due to high
rate of urinary tract infections, VA proposes that this condition may
be rated as voiding dysfunction or urinary tract infection, whichever
is predominant. D. Sauerwein, ``Urinary tract infection in patients
with neurogenic bladder dysfunction,'' 19(6) Int'l J. of Antimicrobial
Agents 592-97 (2002).

G. New Proposed DC 7543

VA proposes the introduction of new DC 7543, ``Varicocele/
Hydrocele,'' to reflect related conditions of the urinary tract that
have not previously been recognized for disability evaluation purposes.
Varicocele is a dilatation of the veins along the cord that receives
blood from the testicles. Hydrocele is a collection of fluid in the
scrotum.
The medical community now recognizes that these conditions may be
associated with a decrease in fertility and, in rare instances, may be
associated with infertility. Center for Male Reproductive Medicine and
Vasectomy Reversal, ``Varicocele Repair,'' http://www.malereproduction.com/male-infertility/treatment/varicocele-repair.php (last accessed April 16, 2014). As a decrease in fertility,
or the existence of infertility, does not cause a reduction in earning
capacity, VA proposes to assign a 0 percent evaluation to these
conditions. In instances where there is a clinical finding of
infertility, these conditions may support eligibility for SMC due to
loss of use of a creative organ. Therefore, to best administer this
benefit, VA proposes a diagnostic code for these conditions that
provides a 0 percent evaluation. Section 4.115b's footnote directing
consideration of SMC would apply to DC 7543, consistent with the other
DCs in the VASRD addressing a creative organ.

H. New Proposed DC 7544

VA proposes the introduction of new DC 7544, ``Renal disease caused
by viral infection such as HIV, Hepatitis B, and Hepatitis C,'' to
reflect renal dysfunctions associated with HIV and hepatitis because of
increasing prevalence and incidence of diseases caused by these
viruses. Perico Norberto et al., ``Hepatitis C Infection and Chronic
Renal Diseases,'' 4(1) Clinical J. Am. Soc'y of Nephrology 207-20
(2009). Hepatitis A, an acute liver disease, does not cause chronic
renal disease and is therefore not included in this DC.
VA proposes to evaluate this DC as renal dysfunction under Sec.
4.115a because, when the liver is damaged due to Hepatitis B or C
infection, the accumulation of toxins in the blood can damage the
kidneys, causing renal dysfunction. HIV-associated renal dysfunctions
have several different etiologies, but can include direct HIV infection
of the kidney, kidney damage caused by drugs used to treat HIV, and
fluid loss caused by various processes associated with the advanced
disease process. Moro O. Salifu, ``HIV-Associated Nephropathy,''
Medscape, http://emedicine.medscape.com/article/246031-overview (Vecihi
Batuman ed., 2013) (last accessed April 16, 2014).

I. New Proposed DC 7545

VA proposes the introduction of new DC 7545, ``Bladder,
diverticulum of.'' Currently, there is no DC for diverticulum of the
bladder and, as such, it is generally evaluated in the field as
analogous to fistula of the bladder. A bladder fistula is an abnormal
connection between the bladder and another organ of the body (e.g., the
bowel). A bladder diverticulum is an abnormal pouch or sac due to
weakness in the bladder's muscular wall that allows a portion of the
bladder to protrude. Urology Care Foundation, ``Urology A-Z: Bladder
Diverticulum,'' http://www.urologyhealth.org/urology/index.cfm?article=111 (last accessed April 16, 2014). The two
conditions have dissimilar symptomatology and result in dissimilar
functional impairment. A bladder fistula allows

[[Page 35144]]

urine to escape the confines of the bladder into another space such as
the rectum, or externally, causing urinary leakage. A bladder
diverticulum allows urine to remain in the bladder longer, often
resulting in infection as well as voiding dysfunction.
The proposed addition of this new DC would ensure that the
condition is more appropriately rated. VA proposes to rate DC 7545 as
voiding dysfunction or urinary tract infection, whichever is
predominant, because these criteria best capture the functional
impairment associated with this condition.

Executive Orders 12866 and 13563

Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, and other advantages; distributive impacts;
and equity). Executive Order 13563 (Improving Regulation and Regulatory
Review) emphasizes the importance of quantifying both costs and
benefits, reducing costs, harmonizing rules, and promoting flexibility.
Executive Order 12866 (Regulatory Planning and Review) defines a
``significant regulatory action,'' which requires review by the Office
of Management and Budget, as ``any regulatory action that is likely to
result in a rule that may: (1) Have an annual effect on the economy of
$100 million or more or adversely affect in a material way the economy,
a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local, or tribal
governments or communities; (2) Create a serious inconsistency or
otherwise interfere with an action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlements, grants, user
fees, or loan programs or the rights and obligations of recipients
thereof; or (4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
this Executive Order.''
VA has examined the economic, interagency, budgetary, legal, and
policy implications of this regulatory action, and it has been
determined not to be a significant regulatory action under Executive
Order 12866.
VA's impact analysis can be found as a supporting document at
www.regulations.gov, usually within 48 hours after the rulemaking
document is published. Additionally, a copy of this rulemaking and its
impact analysis are available on VA's Web site at www.va.gov/orpm/, by
following the link for VA Regulations Published from FY 2004 Through
Fiscal Year to Date.

Regulatory Flexibility Act

The Secretary hereby certifies that this proposed rule would not
have a significant economic impact on a substantial number of small
entities as they are defined in the Regulatory Flexibility Act, 5
U.S.C. 601-612. This proposed rule would directly affect only
individuals and would not directly affect any small entities.
Therefore, pursuant to 5 U.S.C. 605(b), this proposed rule would be
exempt from the initial and final regulatory flexibility analysis
requirements of sections 603 and 604.

Unfunded Mandates

The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C.
1532, that agencies prepare an assessment of anticipated costs and
benefits before issuing any rule that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100 million or more (adjusted annually for
inflation) in any one year. This proposed rule would have no such
effect on State, local, and tribal governments, or on the private
sector.

Paperwork Reduction Act

This proposed rule contains no provisions constituting a collection
of information under the Paperwork Reduction Act of 1995 (44 U.S.C.
3501-3521).

Catalog of Federal Domestic Assistance

The Catalog of Federal Domestic Assistance program numbers and
titles affected by this document are 64.009, Veterans Medical Care
Benefits; 64.104, Pension for Non-Service-Connected Disability for
Veterans; 64.109, Veterans Compensation for Service-Connected
Disability.

Signing Authority

The Secretary of Veterans Affairs, or designee, approved this
document and authorized the undersigned to sign and submit the document
to the Office of the Federal Register for publication electronically as
an official document of the Department of Veterans Affairs. Gina S.
Farrisee, Deputy Chief of Staff, Department of Veterans Affairs,
approved this document on May 26, 2017, for publication.

Dated: July 21, 2017.
Michael Shores,
Director, Regulation Policy & Management, Office of the Secretary,
Department of Veterans Affairs.

List of Subjects in 38 CFR Part 4

Disability benefits, Pensions, Veterans.

For the reasons set out in the preamble, the Department of Veterans
Affairs proposes to amend 38 CFR part 4 as follows:

PART 4--SCHEDULE FOR RATING DISABILITIES

0
1. The authority citation for part 4 continues to read as follows:

Authority: 38 U.S.C. 1155, unless otherwise noted.

Subpart B--Disability Ratings

0
2. Revise Sec. 4.115 to read as follows:

Sec. 4.115 Co-Existence of renal and cardiovascular conditions.

Separate ratings are not to be assigned for disability from disease
of the heart and any form of renal disease, on account of the close
interrelationships of cardiovascular diseases. If, however, absence of
a kidney is the sole renal disability, even if removal was required
because of nephritis, the absent kidney and any hypertension or heart
disease will be separately rated. Also, in the event that chronic renal
disease has progressed to the point where regular dialysis is required,
any coexisting hypertension or heart disease will be separately rated.
0
3. Amend Sec. 4.115a by revising the introductory text and the table
entries regarding ``Renal dysfuntion'' and ``Urinary tract infection''
to read as follows:

Sec. 4.115a Ratings of the genitourinary system--dysfunctions.

Diseases of the genitourinary system generally result in
disabilities related to renal or voiding dysfunctions, infections, or a
combination of these. The following section provides descriptions of
various levels of disability in each of these symptom areas. Where
diagnostic codes refer the decision maker to these specific areas of
dysfunction, only the predominant area of dysfunction shall be
considered for rating purposes. Distinct disabilities may be evaluated
separately under this section, pursuant to Sec. 4.14, if the symptoms
do not overlap. Since the areas of dysfunction described below do not
cover all symptoms resulting from genitourinary diseases, specific

[[Page 35145]]

diagnoses may include a description of symptoms assigned to that
diagnosis.

------------------------------------------------------------------------
Rating
------------------------------------------------------------------------
Renal dysfunction:
Chronic kidney disease with glomerular filtration 100
rate (GFR) less than 16 mL/min; or requiring
regular, routine dialysis or kidney transplant.....
Chronic kidney disease with GFR 16 to 29 mL/min..... 80
Chronic kidney disease with GFR 30 to 59 mL/min..... 60
Chronic kidney disease with GFR >=60 mL/min with at
least one of the following:
Albumin/creatinine ratio (ACR) >=2.5 g/gm
(nephrotic range proteinuria); or
Hypertension at least 10 percent disabling under 30
diagnostic code 7101...........................
Chronic kidney disease with GFR >=60 mL/min with at
least one of the following:
Albumin/creatinine ratio (ACR) from 0.03 g/gm to
2.49 g/gm; or
Hypertension that is non-compensable under 0
diagnostic code 7101...........................
Note: GFR, estimated GFR (eGFR), and creatinine
based approximations of GFR will be accepted for
evaluation purposes under this section when
determined to be appropriate and calculated by a
medical professional.

* * * * * * *
Urinary tract infection:
Poor renal function: Rate as renal dysfunction.
Recurrent symptomatic infection requiring drainage 30
by stent or nephrostomy tube; or requiring greater
than 2 hospitalizations per year; or requiring
continuous intensive management....................
Recurrent symptomatic infection requiring 1-2 10
hospitalizations per year or suppressive drug
therapy lasting six months or longer...............
Recurrent symptomatic infection not requiring 0
hospitalization, but requiring suppressive drug
therapy for less than 6 months.....................
------------------------------------------------------------------------

0
4. Amend Sec. 4.115b by:
0
a. Removing diagnostic code 7510.
0
b. Revising diagnostic codes 7508, 7520, 7521, 7522, 7524, 7525, 7527,
7533, 7534, 7537, 7539, 7541, and 7542.
0
c. Adding diagnostic codes 7543, 7544, and 7545.
The revisions and additions read as follows:

Sec. 4.115b Ratings of the genitourinary system--diagnoses.

------------------------------------------------------------------------
Rating
------------------------------------------------------------------------

* * * * * * *
7508 Nephrolithiasis/Ureterolithiasis/Nephrocalcinosis:
Rate as hydronephrosis, except for recurrent stone 30
formation requiring invasive or non-invasive
procedures more than two times/year................

* * * * * * *
7520 Penis, removal of half or more..................... \1\ 30
7521 Penis, removal of glans............................ \1\ 20
7522 Erectile dysfunction, with or without penile \1\ 0
deformity..............................................
Note: Peyronie's disease is not a ratable condition.

* * * * * * *
7524 Testis, removal:
Both................................................ \1\ 30
One................................................. \1\ 0
Note: In cases of the removal of one testis as the
result of a service-incurred injury or disease,
other than an undescended or congenitally
undeveloped testis, with the absence or
nonfunctioning of the other testis unrelated to
service, an evaluation of 30 percent will be
assigned for the service-connected testicular loss.
Testis, undescended, or congenitally undeveloped is
not a ratable disability.
7525 Prostatitis, urethritis, epididymitis, orchitis
(unilateral or bilateral), chronic only:
Rate as urinary tract infection.
For tubercular infections: Rate in accordance with
Sec. Sec. 4.88b or 4.89, whichever is
appropriate.
7527 Prostate gland injuries, infections, hypertrophy,
postoperative residuals, bladder outlet obstruction:
Rate as voiding dysfunction or urinary tract
infection, whichever is predominant.

* * * * * * *
7533 Cystic diseases of the kidneys:
Rate as renal dysfunction.
Note: Cystic diseases of the kidneys include, but
are not limited to, polycystic disease, uremic
medullary cystic disease, medullary sponge kidney,
and similar conditions such as hereditary
nephritis, Alport's syndrome, cystinosis, primary
oxalosis, and Fabry's disease.
7534 Atherosclerotic renal disease (renal artery
stenosis, atheroembolic renal disease, or large vessel
disease, unspecified):
Rate as renal dysfunction.

* * * * * * *
7537 Interstitial nephritis, including gouty
nephropathy, disorders of calcium metabolism:

[[Page 35146]]

Rate as renal dysfunction.

* * * * * * *
7539 Renal amyloid disease:
Rate as renal dysfunction.
Note: This diagnostic code pertains to renal
involvement in secondary glomerulonephritis/
vasculitis and in other systemic diseases, such as
Lupus erythematosus-Systemic lupus erythematosus
nephritis, Henoch-Schonlein syndrome, Scleroderma,
Hemolytic uremic syndrome, Polyarteritis, Wegener's
granulomatosis, other Vasculitis and its
derivatives, Goodpasture's syndrome, sickle cell
disease, and other secondary glomerulonephritis.

* * * * * * *
7541 Renal involvement in diabetes mellitus type I or
II:
Rate as renal dysfunction.
7542 Neurogenic bladder:
Rate as voiding dysfunction or urinary tract
infection, whichever is predominant.
7543 Varicocele/Hydrocele............................... \1\ 0
7544 Renal disease caused by viral infection such as
HIV, Hepatitis B, and Hepatitis C:
Rate as renal dysfunction.
7545 Bladder, diverticulum of:
Rate as voiding dysfunction or urinary tract
infection, whichever is predominant.
------------------------------------------------------------------------
\1\ Review for entitlement to special monthly compensation under Sec.
3.350 of this chapter.

0
5. Amend Appendix A to Part 4 by:
0
a. Adding Sec. 4.115.
0
b. Revising Sec. 4.115a.
0
c. In Sec. 4.115b, revising the entries for diagnostic codes 7508,
7510, 7520 through 7522, 7524, 7525, 7527, 7533, 7534, 7537, 7539,
7541, and 7542.
0
d. In Sec. 4.115b, adding diagnostic codes 7543 through 7545.
The additions and revisions to read as follows:

Appendix A to Part 4--Table of Amendments and Effective Dates Since
1946

----------------------------------------------------------------------------------------------------------------
Diagnostic
Section code No.
----------------------------------------------------------------------------------------------------------------

* * * * * * *
4.115......................................... .............. Retitled and revised [insert effective date of
final rule].
4.115a........................................ .............. Re-designated and revised as Sec. 4.115b; new
Sec. 4.115a ``Ratings of the genitourinary
system-dysfunctions'' added February 17, 1994;
revised [insert effective date of final rule].
4.115b........................................

* * * * * * *
7508 Evaluation February 17, 1994; title, criterion
[insert effective date of final rule].

* * * * * * *
7510 Evaluation February 17, 1994; removed [insert
effective date of final rule].

* * * * * * *
7520 Criterion February 17, 1994; criterion, footnote
[insert effective date of final rule].
7521 Criterion February 17, 1994; criterion, footnote
[insert effective date of final rule].
7522 Criterion September 8, 1994; title, criterion,
note [insert effective date of final rule].

* * * * * * *
7524 Note July 6, 1950; evaluation February 17, 1994;
evaluation September 8, 1994; note [insert
effective date of final rule].
7525 Criterion March 11, 1969; evaluation February
17, 1994; title [insert effective date of final
rule].

* * * * * * *
7527 Criterion February 17, 1994; title [insert
effective date of final rule].

* * * * * * *
7533 Added February 17, 1994; title and note [insert
effective date of final rule].
7534 Added February 17, 1994; title [insert effective
date of final rule].

* * * * * * *
7537 Added February 17, 1994; title [insert effective
date of final rule].

* * * * * * *
7539 Added February 17, 1994; note [insert effective
date of final rule].

* * * * * * *
7541 Added February 17, 1994; title [insert effective
date of final rule].
7542 Added February 17, 1994; criterion [insert
effective date of final rule].

[[Page 35147]]

7543 Added [insert effective date of final rule].
7544 Added [insert effective date of final rule].
7545 Added [insert effective date of final rule].

* * * * * * *
----------------------------------------------------------------------------------------------------------------

0
6. Amend Appendix B to Part 4 by:
0
a. Revising diagnostic codes 7508, 7522, 7525, 7527, 7533, 7534, 7537,
and 7541.
0
b. Removing diagnostic code 7510;
0
c. Adding diagnostic codes 7543 through 7545.
The revisions and additions read as follows:

Appendix B to Part 4--Numerical Index of Disabilities

------------------------------------------------------------------------
Diagnostic code No.
------------------------------------------------------------------------
The Genitourinary System
------------------------------------------------------------------------

* * * * * * *
7508.............................. Nephrolithiasis/Ureterolithiasis/
Nephrocalcinosis.

* * * * * * *
7522.............................. Erectile dysfunction.

* * * * * * *
7525.............................. Prostatitis, urethritis,
epididymitis, orchitis (unilateral
or bilateral), chronic only.
7527.............................. Prostate gland injuries, infections,
hypertrophy, postoperative
residuals, bladder outlet
obstruction.

* * * * * * *
7533.............................. Cystic diseases of the kidneys.
7534.............................. Atherosclerotic renal disease (renal
artery stenosis, atheroembolic
renal disease, or large vessel
disease, unspecified).

* * * * * * *
7537.............................. Interstitial nephritis, including
gouty nephropathy, disorders of
calcium metabolism.

* * * * * * *
7541.............................. Renal involvement in diabetes
mellitus type I or II.

* * * * * * *
7543.............................. Varicocele/Hydrocele.
7544.............................. Renal disease caused by viral
infection such as HIV, Hepatitis B,
and Hepatitis C.
7545.............................. Bladder, diverticulum of.

* * * * * * *
------------------------------------------------------------------------

0
7. Amend Appendix C to Part 4 by:
0
a. Revising the entries for diagnostic codes 7508, 7522, 7525, 7527,
7533, 7537, and 7541.
0
b. Removing the reference to diagnostic code 7510;
0
c. Adding diagnostic codes 7543 through 7545.
The revisions and additions read as follows:

Appendix C to Part 4--Alphabetical Index of Disabilities

------------------------------------------------------------------------
Diagnostic
code No.
------------------------------------------------------------------------

* * * * * * *
Bladder:

* * * * * * *
Diverticulum of..................................... 7545

* * * * * * *
Erectile dysfunction.................................... 7522

* * * * * * *
Interstitial nephritis, including gouty nephropathy, 7537
disorders of calcium metabolism........................

* * * * * * *
Kidney:

[[Page 35148]]

* * * * * * *
Cystic diseases of the.............................. 7533

* * * * * * *
Nephrolithiasis/Ureterolithiasis/Nephrocalcinosis....... 7508

* * * * * * *
Prostate gland injuries, infections, hypertrophy, 7527
postoperative residuals, bladder outlet obstruction....
Prostatitis, urethritis, epididymitis, orchitis 7525
(unilateral or bilateral), chronic only................

* * * * * * *
Renal:

* * * * * * *
Disease caused by viral infection such as HIV, 7544
Hepatitis B, and Hepatitis C.......................

* * * * * * *
Involvement in diabetes mellitus type I or II....... 7541

* * * * * * *
Varicocele/Hydrocele.................................... 7543

* * * * * * *
------------------------------------------------------------------------

[FR Doc. 2017-15765 Filed 7-27-17; 8:45 am]
BILLING CODE 8320-01-P

Federal Register / Vol. 82, No. 144 / Friday, July 28, 2017 / Proposed Rules 35147

Diagnostic
Section code No.

7543 Added [insert effective date of final rule].
7544 Added [insert effective date of final rule].
7545 Added [insert effective date of final rule].

* * * * * * *

■ 6. Amend Appendix B to Part 4 by: ■ b. Removing diagnostic code 7510; The revisions and additions read as
■ a. Revising diagnostic codes 7508, ■ c. Adding diagnostic codes 7543 follows:
7522, 7525, 7527, 7533, 7534, 7537, and through 7545. Appendix B to Part 4—Numerical Index
7541. of Disabilities

Diagnostic code No.

The Genitourinary System

* * * * * * *
7508 ................................................ Nephrolithiasis/Ureterolithiasis/Nephrocalcinosis.

* * * * * * *
7522 ................................................ Erectile dysfunction.

* * * * * * *
7525 ................................................ Prostatitis, urethritis, epididymitis, orchitis (unilateral or bilateral), chronic only.
7527 ................................................ Prostate gland injuries, infections, hypertrophy, postoperative residuals, bladder outlet obstruction.

* * * * * * *
7533 ................................................ Cystic diseases of the kidneys.
7534 ................................................ Atherosclerotic renal disease (renal artery stenosis, atheroembolic renal disease, or large vessel disease,
unspecified).

* * * * * * *
7537 ................................................ Interstitial nephritis, including gouty nephropathy, disorders of calcium metabolism.

* * * * * * *
7541 ................................................ Renal involvement in diabetes mellitus type I or II.

* * * * * * *
7543 ................................................ Varicocele/Hydrocele.
7544 ................................................ Renal disease caused by viral infection such as HIV, Hepatitis B, and Hepatitis C.
7545 ................................................ Bladder, diverticulum of.

* * * * * * *

■ 7. Amend Appendix C to Part 4 by: ■ b. Removing the reference to The revisions and additions read as
■ a. Revising the entries for diagnostic diagnostic code 7510; follows:
codes 7508, 7522, 7525, 7527, 7533, ■ c. Adding diagnostic codes 7543 Appendix C to Part 4—Alphabetical
7537, and 7541. through 7545. Index of Disabilities

Diagnostic
code No.

* * * * * * *
Bladder:

* * * * * * *
asabaliauskas on DSKBBXCHB2PROD with PROPOSALS

Diverticulum of .............................................................................................................................................................................. 7545

* * * * * * *
Erectile dysfunction .............................................................................................................................................................................. 7522

* * * * * * *
Interstitial nephritis, including gouty nephropathy, disorders of calcium metabolism ......................................................................... 7537

* * * * * * *
Kidney:

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35148 Federal Register / Vol. 82, No. 144 / Friday, July 28, 2017 / Proposed Rules

Diagnostic
code No.

* * * * * * *
Cystic diseases of the .................................................................................................................................................................. 7533

* * * * * * *
Nephrolithiasis/Ureterolithiasis/Nephrocalcinosis ................................................................................................................................ 7508

* * * * * * *
Prostate gland injuries, infections, hypertrophy, postoperative residuals, bladder outlet obstruction ................................................ 7527
Prostatitis, urethritis, epididymitis, orchitis (unilateral or bilateral), chronic only ................................................................................. 7525

* * * * * * *
Renal:

* * * * * * *
Disease caused by viral infection such as HIV, Hepatitis B, and Hepatitis C ............................................................................. 7544

* * * * * * *
Involvement in diabetes mellitus type I or II ................................................................................................................................. 7541

* * * * * * *
Varicocele/Hydrocele ........................................................................................................................................................................... 7543

* * * * * * *

[FR Doc. 2017–15765 Filed 7–27–17; 8:45 am] DATES: Written comments must be Ms. Ward can be reached via electronic
BILLING CODE 8320–01–P received on or before August 28, 2017. mail at ward.nacosta@epa.gov.
ADDRESSES: Submit your comments, SUPPLEMENTARY INFORMATION: In the
identified by Docket ID No. EPA–R04– Final Rules Section of this Federal
ENVIRONMENTAL PROTECTION OAR–2017–0365 at http:// Register, EPA is approving the State’s
AGENCY www.regulations.gov. Follow the online SIP revision as a direct final rule
instructions for submitting comments.
without prior proposal because the
40 CFR Part 52 Once submitted, comments cannot be
Agency views this as a noncontroversial
edited or removed from Regulations.gov.
[EPA–R04–OAR–2017–0365; FRL–9965–29– EPA may publish any comment received submittal and anticipates no adverse
Region 4] to its public docket. Do not submit comments. A detailed rationale for the
electronically any information you approval is set forth in the direct final
Air Plan Approval; Kentucky; consider to be Confidential Business rule. If no adverse comments are
Revisions to Louisville; Definitions Information (CBI) or other information received in response to this rule, no
whose disclosure is restricted by statute. further activity is contemplated. If EPA
AGENCY: Environmental Protection
Multimedia submissions (audio, video, receives adverse comments, the direct
Agency (EPA).
etc.) must be accompanied by a written final rule will be withdrawn and all
ACTION: Proposed rule.
comment. The written comment is public comments received will be
SUMMARY: On August 29, 2012, the considered the official comment and addressed in a subsequent final rule
Commonwealth of Kentucky, through should include discussion of all points based on this proposed rule. EPA will
the Kentucky Division for Air Quality you wish to make. EPA will generally not institute a second comment period
(KDAQ), submitted changes to the not consider comments or comment on this document. Any parties
Kentucky State Implementation Plan contents located outside of the primary interested in commenting on this
(SIP) on behalf of the Louisville Metro submission (i.e. on the Web, cloud, or document should do so at this time.
Air Pollution Control District (District). other file sharing system). For
Dated: July 11, 2017.
The Environmental Protection Agency additional submission methods, the full
EPA public comment policy, V. Anne Heard,
(EPA) is proposing to approve a portion
of the submission that modifies the information about CBI or multimedia Acting Regional Administrator, Region 4.
District’s air quality regulations as submissions, and general guidance on [FR Doc. 2017–15738 Filed 7–27–17; 8:45 am]
incorporated into the SIP. Specifically, making effective comments, please visit BILLING CODE 6560–50–P
the revisions pertain to definitional http://www2.epa.gov/dockets/
changes, including the modification of commenting-epa-dockets.
asabaliauskas on DSKBBXCHB2PROD with PROPOSALS

the definition of ‘‘volatile organic FOR FURTHER INFORMATION CONTACT:
compounds’’. EPA is proposing to Nacosta C. Ward, Air Regulatory
approve this portion of the SIP revision Management Section, Air Planning and
because the Commonwealth has Implementation Branch, Air, Pesticides
demonstrated that these changes are and Toxics Management Division, U.S.
consistent with the Clean Air Act. EPA Environmental Protection Agency,
will act on the other portion of KDAQ’s Region 4, 61 Forsyth Street SW.,
August 29, 2012, submittal in a separate Atlanta, Georgia 30303–8960. The
action. telephone number is (404) 562–9140.

VerDate Sep<11>2014 18:10 Jul 27, 2017 Jkt 241001 PO 00000 Frm 00022 Fmt 4702 Sfmt 9990 E:\FR\FM\28JYP1.SGM 28JYP1

Document Created: 2017-07-28 03:10:36
Document Modified: 2017-07-28 03:10:36

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Proposed rule.
Dates		Comments must be received on or before September 26, 2017.
Contact		Ioulia Vvedenskaya, M.D., M.B.A., Medical Officer, Part 4 VASRD Regulations Staff (211C), Compensation Service, Veterans Benefits Administration, Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 461-9752. (This is not a toll-free telephone number.)
FR Citation		82 FR 35140
RIN Number		2900-AP16
CFR Associated		Disability Benefits; Pensions and Veterans